In accordance with Article 5(7), Regulation (EC) No 141/2000 of 16 December 1999, where the opinion of the Committee for Orphan Medicinal Products (COMP) is that an application does not satisfy the criteria for orphan medicinal product designation, the Agency shall forthwith inform the sponsor. Within 90 days of the receipt of the opinion, the sponsor may submit detailed grounds for appeal, which the Agency shall refer to the COMP. The Committee shall consider whether its opinion should be revised at the following meeting.


The EMA publishes procedural advice on appeal procedure for orphan medicinal product designation or review of orphan designation criteria at the time of Marketing Authorisation.


Posted on the EMA website on 8 May 2013